Penicillin G Sodium
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4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino-],2S-(2a,5a,6b-,monosodium salt.
Monosodium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate [69-57-8].
»Penicillin G Sodium has a potency of not less than 1500Penicillin G Units and not more than 1750Penicillin G Units per mg.
Packaging and storage—
Preserve in tight containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms,the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards á11ñ—
USP Endotoxin RS.USP Penicillin G Potassium RS.USP Penicillin G Sodium RS.
Identification—
A:
Infrared Absorption á197Kñ.
B:
It responds to the tests for Sodium á191ñ.
Crystallinity á695ñ:
meets the requirements.
pHá791ñ:
between 5.0and 7.5,in a solution containing 60mg per mL.
Loss on drying á731ñ—
Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60
for 3hours:it loses not more than 1.5%of its weight.
for 3hours:it loses not more than 1.5%of its weight.
Other requirements—
Where the label states that Penicillin G Sodium is sterile,it meets the requirements for Sterilityand Bacterial endotoxinsunder Penicillin G Sodium for Injection.Where the label states that Penicillin G Sodium must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements for Bacterial endotoxinsunder Penicillin G Sodium for Injection.
Assay—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system—
Proceed as directed in the Assayunder Penicillin G Potassium.
Assay preparation—
Transfer about 5mg of Penicillin G Sodium,accurately weighed,to a 50-mLvolumetric flask,add about 45mLof water,and shake to dissolve.Dilute with water to volume,and mix.
Procedure—
Proceed as directed in the Assayunder Penicillin G Potassium.Calculate the potency,in Penicillin G Units per mg,of Penicillin G Sodium taken by the formula:
(PWS/WU)(rU/rS),
in which WUis the weight of Penicillin G Sodium taken to prepare the Assay preparation,and the other terms are as defined therein.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1496
Pharmacopeial Forum:Volume No.27(1)Page 1814
Phone Number:1-301-816-8335